SPINART

A prospective perspective in prophylaxis

  • Open‑label, randomised, controlled, parallel‑group, multi‑national trial
  • Investigating the benefits of routine prophylaxis vs. on‑demand treatment with rFVIII
  • Males with severe haemophilia A, aged 12‑50, previously treated with rFVIII (≥150 days) and no inhibitors were enrolled

 

Primary endpoint1

  • Number of total bleeding episodes (BEs) in each treatment group after 1 year of treatment

Secondary endpoint1

  • Mean change from baseline to year 3 on the MRI scale, Colorado Adult Joint Assessment Scale, Haemo‑Qol‑A physical functioning domain

 

Reducing BEs

Prophylaxis reduced BEs vs. on‑demand treatment1

Adapted from reference 1

“In adults with severe haemophilia A, routine prophylaxis with rFVIII is more effective than on‑demand treatment in controlling bleeding episodes ‑ including bleeding into joints.”1

 

Reducing total bleeds

During a median treatment time of 1.4 years, secondary prophylaxis with KOGENATE® Bayer significantly decreased median BEs and median joint BEs vs. on‑demand treatment (ITT population):1

 

Adapted from reference 1.

*On‑demand vs. prophylaxis, adjusted for stratification variables (presence/absence of target joint and number of previous BEs). Data shown are for all discontinued patients who completed at least 1 study year.

 

“When bleeding occurred, the most common self‑reported ratings of severity were mild (44%) for prophylaxis and moderate (58%) for on‑demand patients, perhaps because of residual FVIII circulating in plasma when breakthrough bleeding occurred.”1

 

  • Prophylaxis patients also experienced substantially fewer annualised spontaneous (median 0 vs. 19.8) and trauma‑related (median 0 vs. 7.9) BEs vs. on‑demand patients1

 

“The benefits of prophylaxis in patients with severe haemophilia A are greatest when prophylaxis is started at a young age (<2 years). However, as data from the first year of SPINART show, prophylaxis can also improve outcomes vs. on‑demand treatment when started in adulthood.”1

Reference:

  1. Manco-Johnson MJ et al. J Thromb Haemost 2013;11:1119-1127 [published correction appears in J Thromb Haemost 2014;12:119-122.].